Raab AM1, Brinkhof MWG2, Berlowitz D3, Postma K4, Gobets D5, Hirschfeld S6, Huber B7, Hund-Georgiadis M8, Jordan X9, Schubert M10, Wildburger R11, Hopman M12, Mueller G1
1Swiss Paraplegic Centre Nottwil, Clinical Trial Unit, Nottwil, Switzerland, 2Swiss Paraplegic Research, Nottwil, Switzerland, 3Institute for Breathing and Sleep, Austin Health, Heidelberg, Australia, 4Rijndam Rehabilitation Institute, Rotterdam, Netherlands, 5Heliomare Rehabilitation Center, Wijk aan Zee, Netherlands, 6BG-Trauma Hospital, Hamburg, Germany, 7Rehabilitation Center Häring, Häring, Austria, 8REHAB Basel, Basel, Switzerland, 9Clinique Romande de Réadaptation, Sion, Switzerland, 10Spinal Cord Injury Center, Balgrist University Hospital, Zurich, Switzerland, 11Rehabilitation Clinic Tobelbad, Tobelbad, Austria, 12Department of Physiology, Radboud University Nijmegen, Nijmegen, Netherlands
Background: Pneumonia is a common complication after spinal cord injury and enduring one of the leading causes of death. In acute spinal cord injury up to 80% are affected by respiratory complications that may comprise pneumonia in up to 50%. To effectively reduce pneumonia risk and pneumonia-related hospitalizations, clinicians are reliant on prognostic factors that identify persons who are at heightened risk of developing pneumonia. Promising prognostic factors include parameters of lung function, in particular inspiratory muscle strength.
Purpose: To convey the protocol and progress of the RESCOM study that aims to evaluate the prognostic value of inspiratory muscle strength for pneumonia risk in spinal cord injury.
Methods: RESCOM is a prospective cohort study that is operational since October 2016 in 10 specialized spinal cord injury centers from Austria, Australia, Germany, The Netherlands and Switzerland. Eligible are newly injured persons admitted for inpatient rehabilitation, with lesion grades AIS A-D and lesion level C1-T12, who are aged 18 years or older, and not depend on 24-hour mechanical ventilation. The target sample size is 625 participants with interim-analyses at 500 participants.
The primary outcome parameter pneumonia is clinically diagnosed using a pneumonia flow diagram including the methods X-ray, signs and symptoms and laboratory.
Secondary outcome parameters are pneumonia-related mortality (medical records) and quality of life is evaluated (questionnaire).
The primary diagnostic biomarker inspiratory muscle strength is measured using a hand-held respiratory pressure meter (Micro RPM, Micro Medical, Hoechberg, Germany); other lung function parameters, measured by spirometry, are used as secondary biomarkers. Further, potentially confounding determinants include the degree of motor and sensory neurological impairment (captured by the AIS impairment scale), lesion level classified as paraplegia or tetraplegia, selected ICD-10 coded co-morbidities and medical complications, partial dependency on mechanical ventilation, and an index of physical activity and respiratory training (questionnaire). Participant characteristics that are collected include gender, age, time since injury, smoking status, individual medication use, vaccination against influenza, and influenza activity (all from medical records). The outcomes and predictors are measured at up to four defined time-points during inpatient rehabilitation, while participant characteristics are assessed at baseline.
The discriminative power of inspiratory muscle strength for prediction of pneumonia risk will be evaluated using receiver operator characteristic (ROC) curves. Multivariable, parametric ROC regression analysis will be used to allow for covariate adjustment.
For further details: ClinicalTrials.gov NCT02891096; Research Gate (https://www.researchgate.net/project/RESCOM-RESpiratory-COMplications-after-Spinal-Cord-Injury).
Results: To date (01.08.2018) 529 patients were eligible for study participation, 227 (43%) were included for participation. Of these 227 included participants, 35 (15%) developed at least one pneumonia event. More than half of these participants (60%) developed pneumonia within the first month of injury. Statistical analyses will be conducted when recruitment ends.
Conclusion(s): RESCOM is the first international study that evaluates predictors of pneumonia from a representative sample of individuals with spinal cord injury.
Implications: Using discriminatory lung parameters clinicians may identify persons with spinal cord injury who are at heightened risk of developing pneumonia during inpatient rehabilitation. Thus, early interventions (e.g. respiratory muscle training) can be targeted to reduce pneumonia risk.
Keywords: Spinal cord injury, inspiratory muscle strength, pneumonia
Funding acknowledgements: This project is funded by Wings for Life, a spinal cord research foundation, grant number WFL-CH-014/16.
Purpose: To convey the protocol and progress of the RESCOM study that aims to evaluate the prognostic value of inspiratory muscle strength for pneumonia risk in spinal cord injury.
Methods: RESCOM is a prospective cohort study that is operational since October 2016 in 10 specialized spinal cord injury centers from Austria, Australia, Germany, The Netherlands and Switzerland. Eligible are newly injured persons admitted for inpatient rehabilitation, with lesion grades AIS A-D and lesion level C1-T12, who are aged 18 years or older, and not depend on 24-hour mechanical ventilation. The target sample size is 625 participants with interim-analyses at 500 participants.
The primary outcome parameter pneumonia is clinically diagnosed using a pneumonia flow diagram including the methods X-ray, signs and symptoms and laboratory.
Secondary outcome parameters are pneumonia-related mortality (medical records) and quality of life is evaluated (questionnaire).
The primary diagnostic biomarker inspiratory muscle strength is measured using a hand-held respiratory pressure meter (Micro RPM, Micro Medical, Hoechberg, Germany); other lung function parameters, measured by spirometry, are used as secondary biomarkers. Further, potentially confounding determinants include the degree of motor and sensory neurological impairment (captured by the AIS impairment scale), lesion level classified as paraplegia or tetraplegia, selected ICD-10 coded co-morbidities and medical complications, partial dependency on mechanical ventilation, and an index of physical activity and respiratory training (questionnaire). Participant characteristics that are collected include gender, age, time since injury, smoking status, individual medication use, vaccination against influenza, and influenza activity (all from medical records). The outcomes and predictors are measured at up to four defined time-points during inpatient rehabilitation, while participant characteristics are assessed at baseline.
The discriminative power of inspiratory muscle strength for prediction of pneumonia risk will be evaluated using receiver operator characteristic (ROC) curves. Multivariable, parametric ROC regression analysis will be used to allow for covariate adjustment.
For further details: ClinicalTrials.gov NCT02891096; Research Gate (https://www.researchgate.net/project/RESCOM-RESpiratory-COMplications-after-Spinal-Cord-Injury).
Results: To date (01.08.2018) 529 patients were eligible for study participation, 227 (43%) were included for participation. Of these 227 included participants, 35 (15%) developed at least one pneumonia event. More than half of these participants (60%) developed pneumonia within the first month of injury. Statistical analyses will be conducted when recruitment ends.
Conclusion(s): RESCOM is the first international study that evaluates predictors of pneumonia from a representative sample of individuals with spinal cord injury.
Implications: Using discriminatory lung parameters clinicians may identify persons with spinal cord injury who are at heightened risk of developing pneumonia during inpatient rehabilitation. Thus, early interventions (e.g. respiratory muscle training) can be targeted to reduce pneumonia risk.
Keywords: Spinal cord injury, inspiratory muscle strength, pneumonia
Funding acknowledgements: This project is funded by Wings for Life, a spinal cord research foundation, grant number WFL-CH-014/16.
Topic: Neurology: spinal cord injury
Ethics approval required: Yes
Institution: Approved by the responsible ethic committees of all participating centers.
Ethics committee: ethics committee northwest and central Switzerland
Ethics number: 2016/01065
All authors, affiliations and abstracts have been published as submitted.
